AccessGUDID - DEVICE: PREMIER C. difficile GDH (00840733101687)

GUDID

Device Identifier (DI) Information

Brand Name: PREMIER C. difficile GDH
Version or Model: 611096
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 611096
Company Name: MERIDIAN BIOSCIENCE, INC.

Primary DI Number: 00840733101687
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092815364 *Terms of Use

Device Description: Premier C. difficile GDH is a qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from symptomatic persons suspected of having C. difficile infection (CDI). This test does not distinguish between toxigenic and non-toxigenic strains of C. difficile. Samples from symptomatic patients that produce positive results with this test must be further tested with an assay designed to detect toxigenic C. difficile strains and assist with the diagnosis of CDI.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
50832	Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Clostridium difficile bacteria [e.g., glutamate dehydrogenase antigen (GDA), toxin A and/or toxin B] in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCB	Antigen, C. Difficile

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110620	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9db30b8e-4089-47d6-af03-0601cce56ff7
Public Version Date: September 29, 2020
Public Version Number: 1
DI Record Publish Date: September 21, 2020